ClearVu Mini Ceramic Brackets

GUDID 00192029003244

Lower Left 1st Bicuspid/Lower Left 2nd Bicuspid with Hook Torque -17, Tip 0 , 0.46 mm (.018"), Bondable

TP ORTHODONTICS INC

Orthodontic bracket, ceramic

Primary Device ID	00192029003244
NIH Device Record Key	ca772cb1-5cf3-46ef-a914-2444fba1174d
Commercial Distribution Status	In Commercial Distribution
Brand Name	ClearVu Mini Ceramic Brackets
Version Model Number	297-288CV
Company DUNS	005432299
Company Name	TP ORTHODONTICS INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Operating and Storage Conditions

Storage Environment Temperature

Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029003244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K950992

FDA Product Code

NJM	Bracket, ceramic, orthodontic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-11
Device Publish Date	2019-02-19

On-Brand Devices [ClearVu Mini Ceramic Brackets]

00192029005651	Bi-Dimensional Brackets with Hooks 0.46 mm (.018") centrals and laterals with 0.56 mm (.0
00192029005637	Bi-Dimensional Brackets with Hooks 0.46 mm (.018") centrals and laterals with 0.56 mm (.0
00192029005606	Lower Right Cuspid with Distal Hook Torque 0 , Tip +3 , 0.56 mm (.022"), Bondable
00192029005569	Lower Right Cuspid with Distal Hook Torque 0 , Tip +3 , 0.46 mm (.018"), Bondable
00192029005521	Lower Right Cuspid with Distal Hook Torque 0 , Tip +3 , 0.46 mm (.018"), Bondable
00192029005484	Lower Left Cuspid with Distal Hook Torque 0 , Tip +3 , 0.46 mm (.018") Bondable
00192029005446	Lower Right Cuspid with Distal Hook Torque -11 , Tip +6 , 0.56 mm (.022"), Bondable
00192029005408	Lower Right Cuspid with Distal Hook Torque -11 , Tip +6 , 0.56 mm (.022"), Bondable
00192029005361	Lower Right Cuspid with Distal Hook Torque -11 , Tip +6 , 0.46 mm (.018"), Bondable
00192029005323	Lower Left Cuspid with Distal Hook Torque -11 , Tip +6 , 0.46 mm (.018"), Bondable
00192029005286	Upper Right Cuspid with Distal Hook Torque 0 , Tip +8 , 0.56 mm (.022"), Bondable
00192029005248	Upper Left Cuspid with Distal Hook Torque 0 , Tip +8 , 0.56 mm (.022") Bondable
00192029005200	Upper Right Cuspid with Distal Hook Torque 0 , Tip +8 , 0.46 mm (.018"), Bondable
00192029005163	Upper Left Cuspid with Distal Hook Torque 0 , Tip +8 , 0.46 mm (.018") Bondable
00192029005125	Upper & Lower 5-5 Cuspid/Bicuspid with Hooks, 0.56 mm (.022") Bondable
00192029005088	Upper & Lower 5-5 Cuspid/Bicuspid with Hooks, 0.46 mm (.018") Bondable
00192029005040	Upper 5-5 Cuspid/Bicuspid with Hooks, 0.56 mm (.022") Bondable
00192029005002	Upper 5-5 Cuspid/Bicuspid with Hooks, 0.46 mm (.018") Bondable
00192029004968	Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022") Bondable
00192029004920	Upper & Lower 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018") Bondable
00192029004883	Upper 5-5 Cuspid/Bicuspid with Hooks 0.56 mm (.022") Bondable
00192029004845	Upper 5-5 Cuspid/Bicuspid with Hooks 0.46 mm (.018") Bondable
00192029004661	Upper & Lower 3-3 Cuspid With Hooks, 0.56 mm (.022") Bondable
00192029004654	Upper & Lower 3-3 Cuspid With Hooks, 0.46 mm (.018") Bondable
00192029004630	Upper 3-3 Cuspid With Hooks, 0.56 mm (.022") Bondable
00192029004616	Upper 3-3 Cuspid With Hooks, 0.46 mm (.018") Bondable
00192029004500	Lower Universal Anteriors Narrow Torque -6 , Tip 0 , 0.56 mm (.022"), Bondable
00192029004463	Lower Universal Anteriors Narrow Torque -6 , Tip 0 , 0.46 mm (.018"), Bondable
00192029004340	Upper Right Lateral Torque +10 , Tip +8 , 0.56 mm (.022"), Bondable
00192029004302	Upper Left Lateral Torque +10 , Tip +8 , 0.56 mm (.022"), Bondable
00192029004265	Upper Right Lateral Torque +10 , Tip +8 , 0.46 mm (.018"), Bondable
00192029004227	Upper Left Lateral Torque +10 , Tip +8 , 0.46 mm (.018"), Bondable
00192029004180	Upper Right Central Torque +17 , Tip +4 , 0.56 mm (.022"), Bondable
00192029004142	Upper Left Central Torque +17 , Tip +4 , 0.56 mm (.022"), Bondable
00192029004104	Upper Right Central Torque +17 , Tip +4 , 0.46 mm (.018"), Bondable
00192029004067	Upper Left Central Torque +17 , Tip +4 , 0.46 mm (.018"), Bondable
00192029003909	Lower Right 1st Bicuspid with Hook Torque -12 , Tip 0 , 0.56 mm (.022"), Bondable
00192029003848	Lower Left 1st Bicuspid with Hook Torque -12 , Tip 0 , 0.56 mm (.022") Bondable
00192029003787	Lower Right 1st Bicuspid with Hook Torque -12 , Tip 0 , 0.46 mm (.018"), Bondable
00192029003725	Lower Left 1st Bicuspid with Hook Torque -12 , Tip 0 , 0.46 mm (.018"), Bondable
00192029003664	Lower Right 2nd Bicuspid with Hook Torque -22 , Tip 0 , 0.56 mm (.022"), Bondable
00192029003602	Lower Left 2nd Bicuspid with Hook Torque -22 , Tip 0 , 0.56 mm (.022") Bondable
00192029003541	Lower Right 2nd Bicuspid with Hook Torque -22 , Tip 0 , 0.46 mm (.018"), Bondable
00192029003480	Lower Left 2nd Bicuspid with Hook Torque -22 , Tip 0 , 0.46 mm (.018") Bondable
00192029003428	Lower Right 1st Bicuspid/Lower Right 2nd Bicuspid with Hook Torque -17 Tip 0 , 0.56 mm (.022"),
00192029003367	Lower Left 1st Bicuspid/Lower Left 2nd Bicuspid with Hook Torque -17, Tip 0 , 0.56 mm (.022"),
00192029003305	Lower Right 1st Bicuspid/Lower Right 2nd Bicuspid with Hook Torque -17 Tip 0 , 0.46 mm (.018")
00192029003244	Lower Left 1st Bicuspid/Lower Left 2nd Bicuspid with Hook Torque -17, Tip 0 , 0.46 mm (.018"),
00192029003183	Roth UR Unv. Bicuspid w / Hk; MBT UL Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.56 mm (.022"), B
00192029003121	Roth UL Unv. Bicuspid w / Hk; MBT UR Unv. Bicuspid w / Hk -7 Torque, 0 Tip, 0.56 mm (.022"), B